Efficacy, Safety and Tolerability of Atorvastatin 40 mg in Patients With Relapsing-remitting Multiple Sclerosis Treated With Interferon-beta-1b

NCT01111656 | Completed Phase 2 DMC

• 1 other identifier: 75/07
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

The "SWiss Atorvastatin and Interferon-Beta 1b Trial In Multiple Sclerosis - Follow up Study" is the follow up study of the "SWiss Atorvastatin and Interferon Beta-1b Trial In Multiple Sclerosis (SWABIMS)" (see http://www.clinicaltrials.gov. Identifier: NCT00942591) SWABIMS evaluated the efficacy, safety and tolerability of atorvastatin 40 mg in addition to interferon-beta 1b compared to interferon-beta 1b monotherapy in patients with relapsing-remitting multiple sclerosis for 15 month. The SWABIMS Follow up study observes patients that finish the SWABIMS study for another 12 month with ongoing unchanged medication.

Conditions

Relapsing-remitting Multiple Sclerosis

Keywords

Multi-center; randomized; prospective; parallel-group; rater-blinded; RR-MS

Outcome Measures

Primary Outcomes (2)

• Proportion of patients with new lesions on T2-weighted images after 12 months of treatment

  Month 0

• Proportion of patients with new lesions on T2-weighted images after 12 months of treatment

  Month 12

Secondary Outcomes (16)

• Gd-enhancing lesions on T1-weighted images after 12 months of treatment.

  Month 0

• Total T2-hyperintense lesion volume (burden of disease, BOD) after 12 months of treatment.

  Month 0

• Cortical atrophy (changes in brain volume, changes in grey matter and white matter) on magnetic resonance imaging (MRI) after 12 months of treatment

  Month 0

• Clinical disease progression (Expanded Disability Status Scale [EDSS], Multiple Sclerosis Functional Composite [MSFC] )

  Month 0

• Functional systems scores (of Expanded Disability Status Scale [EDSS] and Multiple Sclerosis Functional Composite [MSFC] )

  Month 0

Study Arms (2)

1

ACTIVE COMPARATOR

Interferon beta-1b 250ug subcutaneously every other day

Drug: Interferon beta-1b group

2

EXPERIMENTAL

Interferon beta-1b 250ug subcutaneously every other day AND atorvastatin 40mg every day (oral)

Drug: Interferon beta-1b/Atorvastatin group

Interventions

Interferon beta-1b group DRUG

Patients receive interferon beta-1b 250ug subcutaneously every other day

1

Interferon beta-1b/Atorvastatin group DRUG

Patients receive interferon beta-1b 250ug subcutaneously every other day AND atorvastatin 40mg every day (oral)

2

Eligibility Criteria

• Age: 18 Years - 67 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Successful completion of the SWABIMS study
• Written informed consent

You may not qualify if:

• Any disease other than multiple sclerosis that would better explain the patient's signs and symptoms
• Secondary progressive MS
• Uncontrolled severe medical disorder
• Participation in any other studies

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead
• Viollier AG, Basel, Switzerland: collaborator
• PharmaPart: collaborator

Study Sites (1)

Department of Neurology, Bern University Hospital, and University of Bern

Bern, Canton of Bern, 3007, Switzerland

Location

Related Publications (4)

• Kamm CP, Mattle HP; SWABIMS Study Group. SWiss Atorvastatin and interferon Beta-1b trial In Multiple Sclerosis (SWABIMS)--rationale, design and methodology. Trials. 2009 Dec 14;10:115. doi: 10.1186/1745-6215-10-115.

  PMID: 20003436 BACKGROUND

• Youssef S, Stuve O, Patarroyo JC, Ruiz PJ, Radosevich JL, Hur EM, Bravo M, Mitchell DJ, Sobel RA, Steinman L, Zamvil SS. The HMG-CoA reductase inhibitor, atorvastatin, promotes a Th2 bias and reverses paralysis in central nervous system autoimmune disease. Nature. 2002 Nov 7;420(6911):78-84. doi: 10.1038/nature01158.

  PMID: 12422218 BACKGROUND

• Kwak B, Mulhaupt F, Myit S, Mach F. Statins as a newly recognized type of immunomodulator. Nat Med. 2000 Dec;6(12):1399-402. doi: 10.1038/82219.

  PMID: 11100127 BACKGROUND

• Kamm CP, El-Koussy M, Humpert S, Findling O, Burren Y, Schwegler G, Donati F, Muller M, Muller F, Slotboom J, Kappos L, Naegelin Y, Mattle HP; SWABIMS Study Group. Atorvastatin added to interferon beta for relapsing multiple sclerosis: 12-month treatment extension of the randomized multicenter SWABIMS trial. PLoS One. 2014 Jan 30;9(1):e86663. doi: 10.1371/journal.pone.0086663. eCollection 2014.

  PMID: 24497963 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Heinrich Mattle, Prof.

  Dep. of Neurology, Bern University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 15, 2010
• First Posted: April 27, 2010
• Study Start: March 1, 2007
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: September 7, 2011

Record last verified: 2011-09

Locations

CH (1)